1. Field of the Invention
The present invention relates to cost-effective and readily realizable means to reduce the possibility of unintentionally cutting or cauterizing a patient, or new born, in proximately of an electrosurgical handpiece.
2. Discussion of Background
The first documented case of cutting or cauterizing patients using electricity was in 1910 and later, in 1920, perfected by electrophysicist William Bovie and neurosurgeon Harvey Cushing when they collaborated in the development of modern electrosurgery.
Even though modern designs have improved capabilities they all essentially follow Bovie's initial design and the basic principle of operation has not changed.
That is, the vast majority of modern electrosurgical equipment today consists of a radio frequency current generator and handpiece that passes electrical current through tissue for the purpose of cutting or coagulating. It combines the principle of electricity and cautery in that it uses heat to destroy tissue or coagulate blood.
The handpiece is traditionally a passive pencil like device that is simply composed of a metal blade, switches that are used by the surgeon to select one of two modes of operation, a length of cable, and a connector to an electrosurgical generator that also renders replacement of the handpiece without wiring.
It is well documented in medical literature that on occasion electrosurgical handpieces fail and either self activate or are unable to become activated by the surgeon. Unfortunately these failures, if annunciated at all, are annunciated only on the remotely located generator and owing to background noise in the operating suite often not heard or seen by the surgeon. These self activating failures can and have caused patients to experience severe burns and in at least one occasion loss of an infant's toes during delivery. Further, when the handpiece fails to activate the surgeon's conditioned response is to try a different location on a patient, in an area removed from the surgical area, to test the handpiece. This trial and error approach causes unnecessary lesions in the patient.
Virtually all manufacturers of handpieces provide an insulated plastic holster that the surgeon is supposed to place the handpiece in, at bedside, whenever it is not in use and thereby avoid any possible contact with the patient. This has proved difficult because traditionally there is more than one surgeon attending the patient at any one time. Additionally, out of necessity the surgeons are located on opposite sides of the patient making it difficult to have a central location for the handpiece.
Recently a patent, by Allen et al. U.S. Pat. No. 6,986,768 B2, has been issued in an attempt to solve the problem by having a shield slide over the handpiece blade when the handpiece is not in use. This would mitigate, but not solve, the problem as it would require a surgeon to constantly slide the shield on and off—and that's probably not going to happen.
To date there have been numerous patents issued and suggestions submitted in an attempt to resolve the issue of failures associated with handpieces by various means. Some of these, as above, suggest implementation of physical obstacles while others attempt to provide a visual indication of operation on or in proximity to the handpiece. Unfortunately the vast majority of patents issued, notably by Nardella and Yates, U.S. Pat. No. 5,817,091, Miller, Rader, Wells and Stoppel, U.S. Pat. Nos. 6,534,770 B2 & 6,984,826 B2, Wampler, Yates, Speeg, Vaitekunas, Drake and Niezgoda U.S. Pat. No. 6,676,660 B2, Orszulak and Dobbins U.S. Pat. No. 6,685,701 B2 don't solve the problem. This is because the devices are: to complex, require wiring, require power, are expensive, not easily sterilized, are difficult to retrofit existing handpieces, physically interfere, and potentially interfere with the handpiece's electric field.
Without reservation, the most important issue in the implementation of any solution to this problem is its use and acceptance by surgeons.
Therefore as exemplified, the solution must be: cost effective, reliable, safe, not effect surgical procedures, compatible with existing technology and simple—all of which this present invention uniquely satisfies.